ABSTRACT
Objective -This protocol outlines the various steps of a research study on the treatment of overweight anxious subjects. The aim is the one of confronting the findings obtained by researchers with different kinds of approach, and producing a multicentric clinical trial. In particular, the protocol is the one adopted by the Carma Centre (Centre for Advanced Research an Mental Aid – Udine, Italy), which uses innovative methods such as vibroacoustics, the restricted environmental stimulation therapy, and 4D virtual reality.
Method – We will consider a sampling unit of 24 people (12 men and 12 women) who will be recruited after some tests. In order to state if they are eligible candidates, first their level of anxiety will be evaluated using biofeedback parameters and the Hamilton scale, while their overweight conditions will be determined through a Bio/Mass index. Before starting the treatment with the equipment described below, also the Likert scale will be administered. The efficacy of the method will be monitored in the course of biofeedback sessions. At the end of the cycle the level of improvement will be examined from a clinical viewpoint and within a statistical survey which will be carried out through descriptive and inferential methods.
Equipment - 4DVR Simulator to produce conditioned effects. The patient is reached by stimuli that are created in a virtual form, within a computer-generated situation. Flotation Tank, to induce complete relaxation where it is easier to receive the proper inputs. The tank consists of a closed container, filled with dense water and Epsom salt solution heated at 35° C. The effectiveness of isolation will be enhanced using audio-visual stimulation. Vibroacoustic Polisensory Bed, to exploit the sound properties and produce health benefits. A therapist will control the physical response to vibrations and decide the range of frequencies to be applied after a sound-respondency test.
AUTHORS
the team working for the Carma Centre:
Raffaelli Alberto - Barbina Adriana - Esposito Pier Luigi - Fragiacomo Tullio - Kriscak Diego - Mullich Laura- Rizzo Claudio.
C.A.R.M.A. srl (Centre for Advanced Research and Mental Aid)
Udine, ITALY
www.carmareality.it
e-mail: carmareality@yahoo.it
FOREWORD
Anxiety and Nervous Hunger
Anxiety is characterized by a sensation of light suffering which is not connected with any specific stimulus. Sometimes it has been defined as apprehension, stress or uneasiness which derive from the expectation of a danger coming from inside or outside the individual. Some authors distinguish anxiety from fear, limiting it to the anticipation of a danger the source of which is completely unknown; fear, instead, would be the response to an external threat or danger which are consciously recognized. The distinction is based on the difference between what is conscious and what is unconscious, even if there is always a latent state of fear at heart.
The somatic manifestations of anxiety and fear are the same: motorial tension, neurovegetative hyperactivity, suspense, alertness and alarm, sensations which are not related to any particular stimulus. There is also a form of anxiety with a dominant symptom characterized by a strong desire to eat (which is not to be classified as bulimia nervosa).
The brain centre which regulates the sense of hunger and satiation is the hypothalamus: the median nucleus, when disturbed, causes excessive hunger while the ventral nucleus reduces the need for food.
Anxiety causes a state of chronic stress that involves amygdala; so there is an increase in the synthesis of dopamine which, acting on the hypothalamus, causes anxious hunger. There is also a production of adrenaline, which inhibits the synthesis of corticotrophin that is responsible for the reduction of appetite. Hence the continuous sense of hunger produced by the state of anxiety.
The main antagonist of noradrenaline is serotonin, which stimulates the release of CRH with a consequent sensation of satiation. This neurotransmitter is produced not only at the level of encephalon but, above all, by the chromaffin cells of the submucous and myocentric plexus of the intestine (in situ it stimulates peristalsis). The intestine, as an “abdominal brain” (Gerson), has a great influence over the “cranial brain”, contributing to the state of mental wellbeing. Stress and anxiety, by chronically activating the reaction to danger, can also alter the intestinal homeostasis, reducing serotonin.
In order to eliminate anxious hunger and then overweight situations which can lead to various types of pathologies, we think it is possible to adopt new technologies such as:
Vibroacoustic interventions at abdominal level for conditioning chromaffin cells, microtubules and ciliated cells;
Infrasound at the frequency of alpha waves, which allows to intervene on the ependymal cells that line the brain ventricles and have long cilia which can easily resonate under mechanical-acoustic stimuli (stimulation in this case would intervene later on the diencephalic nuclei). See F.Bistoli “Suoni e vibrazioni sull’uomo”.
4D Virtual Reality to induce conditional reflexes of food refusal (the kind of food which is more desirable and more risky) acting on the “mirror neurons”.
These therapies have been tested on some patients at the Carma Centre (Udine, Italy) with encouraging results, and that has suggested a comparative experimentation involving researchers that use traditional methods.
The final goal is the one of curing or reducing the disorders by acting on the brain waves. To reach its objective the Centre will use: a Vibroacustic Polisensory Bed, a Flotation Tank and a 4DVirtual Reality Simulator. The basic instruments for objective measurements will be represented by the Biofeedback parameters and the Hamilton scale. The expectation is that the individual responses will develop as a function of the anxiety level and therefore, even establishing a 6 session standard treatment in the course of 2 weeks, supplementary sessions are foreseen at the therapist’s discretion.
BASIC PLAN AND HYPOTHESIS
The present protocol is about the treatment of subjects suffering from food disorders of emotional or anxious nature, by using technologies completely new together with traditional methods. The period of treatment is planned to last 2 weeks, with 3 sessions per week. The ultimate goal at the end of the period is the one of reducing Emotional Eating Disorders (EED) and Binge Eating Disorder (BED). In any case, after considering the results, adjustments are possible, as well as new tests and new sessions when necessary.
Method for Collecting Clinical Data
First of all it is necessary to detect the level of anxiety by means of an objective evaluation tool; that will be done using “Biofeedback”, an instrument which can provide objective measurements of the signs of the disturb as well as the general psychophysical state of a subject (it must be noted that also TMS - transcranic magnetic stimulation- is gaining ground, thanks to its notable outcome).
Doing a psychophysiological profile by biofeedback patterns needs a number of steps which involve stressors and recovery periods. The steps for a quick assessment may be as follow:
- putting on the sensors: the therapist asks the subject to lie down on a bed-pad, stay calm and relax; then he starts putting on the sensors, explaining what he is doing; he will also tell the subject that there will be a baseline with eyes closed and two stressful tasks with eyes open; when he has finished putting on the sensors, he invites the subject to close his eyes;
- collecting data without stress, to obtain a baseline for each subject; it may take from 1 to 3 minutes;
- inducing objective stress: the subject is asked to carry out a cognitive task such as a mental Math Test or the Stroop Colour Word Test (this one with eyes open watching a display);
- base line/recovery period for 3 minutes: the subject is asked to close his eyes and relax; the therapist waits until the parameters being measured return to base line values; anyway the length of time required to recover varies and it may be quite long for some subjects;
- inducing subjective stress: the subject is asked to imagine an anxiety-inducing situation with eyes open; the therapist will tell him to really try to get fully and emotionally involved, in order to experience the same stress without talking about that;
- base line/recovery period for 3 minutes: the subject is asked to close his eyes and relax, possibly using the techniques he is familiar with; recovery to base line levels might be quite long after the task of subjective stress.
Side by side with the evaluation of the anxiety levels by biofeedback, the Cognitive-Behavioural approach will also be followed: in this case the Hamilton Scale will be used and the results will be compared with the biofeedback parameters.
Correlation between Physiological Parameters and Psychological Disturbs
In the assessment of the psychological disturbs, the physiological parameters obtained by biofeedback which are most commonly considered are the muscle tension, the electrodermal potential, the heart frequency, and the brain activity. It is important to underline that, in order to have the possibility of a correct evaluation, it is necessary to take into account more parameters simultaneously, since some subjects may reveal marked variations in some of them, an no variations in others, even if they are suffering from severe psychological disturbs.
Muscle Tension: it is measured by the electromyographic (EMG) signal which detects, through skin electrodes, the variations of the muscle electrical potential. The muscle excitatory potential depends on the excitatory potential which is present in the motor region of the cortex and is connected with the general state of emotional tension. Generally, in order to evaluate the emotional tension, sensors are positioned on the frontal muscles.
Electrodermal activity: this parameter can be measured by skin conductance (Galvanic Skin Response) or the excitatory potential of the sweat glands (Skin Potential Response). The electrodermal activity is closely connected with the psychological process of attention and emotions. As a result we have an index which can be used to evaluate the state of cognitive and emotional activation in a subject. While the GSR generally signals the presence of an emotion, the SPR allows to distinguish between positive and negative emotions. The variations with reference to the base line values are related to the activity of the sweat glands due to the synaptic nerve terminations, together with the variations of the state of alertness of the ascendant reticular formation.
Heart frequency: it is recorded by a pletysmograph which is put on a forefinger or one of the earlobes. As a result we have an index of either the state anxiety or the state of relax. In case the administration of a given stimulus causes a variation of the heart frequency, we can judge the actual power of the same stimulus in eliciting a state of anxiety in the subject.
Brain activity: brain waves are detected by sensors positioned on the scalp and the earlobes. Patterns of alpha, beta, lambda and theta waves are thus obtained - together with their variations, mean values etc.- while index-linked parameters signal the kind of mental circuits being activated.
We can state, supported by a number of studies, that there are physiological profiles and reactions which are typical of each of the commonest psychological disturbs and which an expert can easily detect; moreover, those profiles and reactions are extremely difficult (if not impossible) to be simulated, since the parameters being measured do not depend on the patient’s conscious control.
On the basis of that, if for example, after giving a specific and proper stimulus to a subject who declares to suffer from a phobia, the parameters indicating a neurovegetative activity do not reveal any increase, it is possible to conclude, with a high degree of certainty, that the subject is simply emphasising the perception of his personal experiences. If on the contrary the general psychophysiological profile indicates certain values but no variations connected with the phase of subjective stress, we are allowed to deduce that there has been simulation.
The analysis of the different levels in which activation occurs, the evaluation of the parameters, the length of time required to recover, the confrontation of the values recorded in opposite situations (relaxation versus activation) etc. provide precise, objective, and reliable information which is closely connected with the possible psychic disturb of the subject.
Briefly we can state the following:
subjects lamenting stress disturbs show a general state of continuous alertness, muscle hypertone, tachycardia, vasoconstriction, and peripheral hypothermia;
anxious or phobic subjects show clear alterations of the electrodermal potential and, to a less extent, of the myoelectrical potential, in the presence of ideations or pertinent stimuli;
subjects suffering from depression denounce a reduced electrodermal activity and a high myoelectrical activity in the presence of dysphoric ideations.
Possible objections to the use of the biofeedback modality do not refer to its reliability from a scientific viewpoint, but to the fact that as a test it seems excessively simplified and reductive comparably with the variety and complexity of the mental circuits and processes.
And yet, if some perplexities can be justified when this new kind of approach is selected and applied as the only basic tool or the only means of evaluation in the psychological treatment, there is no reason to hesitate when the same instrument is employed in the domain of diagnoses.
EQUIPMENT FOR CLINICAL USE
4DVR Simulator. Anxiety is usually treated with some success in psychotherapy by putting the patient in a situation where he has to face his problems, that is by gradually exposing him to the feared stimuli. There are three types of the so called exposure-therapy:
1.In vivo: when the patient is subjected to real stimuli which reproduce anxiety-inducing situations.
2.Simulated reality: the patient is exposed to anxiety-inducing stimuli which are, in fact, only imaginary.
3.Virtual reality: the patient is reached by stimuli that do cause anxiety, but are created in a virtual form, within a computer-generated situation.
The tool of “virtual reality” has the merit of creating a more realistic situation than the one produced by “simulated reality”; it is also safer, less embarrassing, and more convenient than the therapy which recreates the stimuli in vivo.
In 1993, researchers at the Universities of Georgia Tech, Clark, Atlanta and Emory (all of them based in Atlanta), soon followed by researchers at the Universities of Washington and Valencia (Spain), started to verify the effectiveness of Virtual Reality in the treatment of phobic neuroses.
Acrophobia (fear of heights) was the first pathology where VR was tried as a therapy and the results were extremely encouraging: in 70% of the patients who were treated with an exposure of 35-45 minutes for 7 days a week, anxiety, anguish, and the “fight or flight” response dropped down. Afterwards this method proved to be a very efficacious remedy not only for other specific phobias (e.g. aracnophobia and fear of flying) but also for social phobias, such as fear of meeting people and agoraphobia (fear of open spaces), as shown by the research carried out by Barbara Rothbaumm (Emory University School of Medicine, Atlanta-Georgia,USA).
It must be underlined that some results, even if achieved with technologies dating back to ten years ago, were undoubtedly satisfactory, as it was shown by appropriate medical instrumentation which could reveal abnormal sweating, loss of balance, and knee-weakness.
Nowadays similar researches are being carried out at the University of Nottingham (England) and at the NTNU of Oslo.
Other findings demonstrate that VR simulation is effective even in the treatment of male erection disorders.
Thanks to technological progress, VR has greatly improved over time, increasingly involving the senses, both in terms quality and number, and successfully activating the sensorial and logical inferences. A growing body of data seems to prove that VR can positively be applied in the treatment of several types of neuroses, such as panic attacks, dysthymia and light forms of depression. Furthermore, considerable results have already been obtained in the realm of autism and in the treatment of obesity.
Today, the discovery of the “mirror neurons” offers a valid justification to the use of this technology.
Flotation Tank - Also known as Isolation Tank, it allows to induce a state of complete relaxation in the patient, depriving him of any sensory stimuli. This method has given excellent results in the treatment of arterial hypertension and the prevention of cardiovascular diseases; it also seems efficacious in the treatment of II type diabetes.
The manifestations of the brain activity produced by “isolation” have been highlighted by the magnetic resonance brain images: their observation has allowed to state that the conscious cognitive part of our brain seems to be able to regulate a very great number of functions of our body through an easy dialogue with the non-cognitive regions.
The state of relaxation would also have a positive effect on the modifications of biorhythms.
Created in 1954 by the neurophysiologist John Lilly at the National Institute for Mental Health in Maryland (NIMH), the “flotation tank” consists of a closed container, filled with dense water and Epsom salt solution (magnesium sulfate) heated at 35° C, which produces an environment with no visibility, deep silence and such a complete tactile absence that the subject floating in the tank can no longer feel the force of gravity. Lilly himself underlined that: “free from the effect of the force of gravity, one is no longer compelled to confront himself with his weight, which imposes to calculate how to move not to fall: a task that takes up 90% of our neuronal activity”.
Recent studies show that the experience of floating reduces the circulatory levels of noradrenaline and MPHG (3-methoxi-4-hydroxyphenylethyleneglycol) while increasing the production of endorphins. In test subjects the level of optimism rises, the degrees of anxiety and depression fall remarkably, and sleep can be attained more easily (A.Kjeligren, U. Sundequist, T. Norlander, Tarcher).
At first the flotation tank was used in the domain of “brain-washing” research and it was highly backed up by the NIMH after the Korean war. It became well-known in 1980, thanks to the film Altered States (a story based on the experience of floating after taking LSD or ketamines). Afterwards, isolation tanks were adopted by many private psychotherapy centres with the personal authorization of John Lilly.
The growth of scientific research on anxiety and stress-related disorders increased the academic interest in the opportunities offered by the restricted environmental stimulation therapy (REST) .
For instance, Michael Hutchinson claims in his books Mega Brain, but also in other works (e.g. Exploration of the Private Sea, which deals with flotation) that while floating in an isolation tank - in total darkness and silence, when you do not need to use the biggest part of your cerebral activity to solve the problem of motion - the brain finds itself devoid of stimuli and the body seems to ‘vanish’; at the same time, the heartbeat slows down, oxygen intake diminishes and the levels of cortisol, ACTH, lactate and adrenaline decrease. All that happens not only during the treatment, but also for many days afterwards. In this ‘vanishing’ state of suspended disbelief the patient experiences the near-death sensation or the prenatal dreamlike states.
The use of the flotation REST at the Medical College of Ohio, as well as the British University of Columbia and the St. Elizabeth Hospital of Wisconsin, has confirmed the power of this therapy in reducing stress. In particular, the endocrinologist John Turner and the psychologist Tom Fine of the Medical College of Ohio, while reaffirming that flotation decreases the level of stress-producing substances, have proved that these effects last over time.
Thomas Budzynski - an expert in cerebral hemisphere reactions to different situations who works at the Medical Centre of the University of Colorado - has pointed out that, when floating, the right hemisphere is in a dominant state, while the left one is dormant: this means that flotation has the power to increase the learning capacities. Gary Stem, of the same University, has noticed an increase in theta waves among patients staying in the tank for at least an hour.
The theta stage, on the borderline between consciousness and unconsciousness, is characterized by vivid and unexpected images, involuntary memories, exciting feelings (those “Eureka” moments when creative ideas or solutions to problems suddenly appear) and sensations of serenity and peace. This stage can be called a “twilight” condition, that is an undefined, vague state of the mind, when the brain is ready to accept any input it may work out.
In the sensory isolation of a tank, even the percentages of serotonin, glutamate and endorphin seem to raise.
There are two types of flotation REST:
1.wet flotation REST: when the patient floats directly in salt water.
2.dry flotation REST: when the patient lies on a polymer membrane that separates him from the water.
The flotation tanks can be equipped with a loudspeaker or a screen, so that patients can receive sound or visual inputs; moreover, thanks to air-vents, they can also inhale therapeutic aromas.
Vibroacoustic Polisensory Bed -
Today we know that sounds act on the non-auditory tissues by mechanisms of different types that involve, on the one hand, the physical properties of the acoustic waves and particularly their coherence, on the other hand the biophysical properties of many tissues: piezoelectricity, semiconductivity, the bipolar character of the water and many organic macro-molecules, including DNA (see F. Bistolfi, Radiotherapy Department, Galliera Hospital, Genoa, Italy).
Sound has always been exploited over time for therapeutic use, both in the form of complex structures (music-therapy) and in the form of single isolated expressions with a particular frequency and vibroacoustic effects. In both cases the action is mediated by the cochlear-auditory way and the somatic physiological effects which result are expression of the involvement of the diencephalic centres of the limbic area. Moreover, in the use of therapeutic sounds it is also considered the direct application of the sound source on given parts of the body, with the aim of utilizing the power of penetration of the acoustic waves and stimulating (by resonance through specific single frequencies) those natural vibrations which, for various reasons, are not normally produced.
The simple mechanical vibration produced by a wave generator intervenes efficaciously especially in the field of low frequencies. The organs of our body vibrate as their own resonance frequencies are approached. These vibrations create strong physical responses with positive results in the treatment of pain and other disorders. (A given sound vibration, for instance, can reduce the hypertone of the extensor and flexor muscles of patients affected by cerebral palsy).
The Carma Centre in Udine (Italy), with its prototype of “vibroacoustic bed“ (which is more properly called “polisensory” since, besides hearing and touching thanks to vibroacoustics, it also stimulates smelling through molecular aromatherapy, and sight through chromotherapy), uses this technique with efficacy.
METHOD FOR RECRUITING THE SAMPLING UNIT
The research which will be conducted with the equipment and the procedures just described aims at recruiting, in the first phase, a sampling unit that should be sufficiently representative of subjects who are overweight because of their state of anxiety. So the following sequence will be considered.
a. Identification of the sampling unit. The sampling unit will be made up of 24 subjects (12 men and 12 women) who are overweight as a consequence of Emotional Eating Disorders and Binge Eating Disorder. The subjects will be equally divided into groups of 8 people each (4M+4F) according to their age: 20-30, 30-40, 40-55. The overweight status of each participant in the research study will be derived from biometric scales or a Body/Mass index (within the values 29-30).
In order to recruit the sample the following strategies will be used:
- advertisements on local papers inviting candidates to phone for an appointment (in our case also proposing free complementary treatments at the Carma Centre);
- leaflet distribution in health centres and public places.
It must be very clear that:
- the aim of the research is merely of scientific nature;
- the handling of personal data is subject to secrecy;
- information will be separated from personal identifiers through the use of a code and therefore it will end up being dissolved in an anonymous statistical universe (a data use agreement will be required anyway).
b. Anamnesis and evaluation of the anxiety level. As already said, the target of our research study is made up by people suffering from EED and BED, that is patients who are in an overweight status as a consequence of their anxiety. Therefore, as an objective method for evaluating their anxiety level and the severity of the disturb, we will use the Hamilton scale and the Biofeedback patterns.
Environmental factors are not included in the properties which characterize the sampling unit, even if, with a view to comparing the results with other research studies, the environment might play a role of some importance. Owing to that, an “environmental stress weight” will be added to the final results (it will practically consist of a proper statistical constant).
c. Inclusion in the sampling unit and treatments. At first participants will be given a biofeedback test in order to obtain their psychophysiological profile. Then they will experience the following treatments:
1. flotation tank: in the general state of sensory deprivation and complete relaxation that the tank produces, sound and visual inputs will be administered (4D VR images);
2. vibroacoustic polisensory bed: on the basis of the biofeedback patterns, a therapist will identify the sound frequency range and values to be administered through somatic and acoustic ways. The infrasound sensible cells (microtubules and ciliated cells) will be particularly stimulated.
3. 4D VR simulator: in order to create conditioned reflexes of refusal of particular types of food.
N.B. Biofeedback will be used in the whole course of the treatment as a helpful monitoring tool.
OPTIONS
a. Personal data and motivations. Among the properties of the sampling unit also the level of education might be taken into account, preferring subjects with a high school/university degree. Moreover, motivation to take part in the research study should be considered, excluding those subjects who do not reveal any interest at all or show an attitude of open refusal.
b. Sessions. The first session will allow to collect information about the physical and emotional state of the subjects. In the next session the Likert scale will be used for measuring the amount and quality of the attitudes which have come to light as to exclude - as we have said - patients with a negative approach.
During the treatment, the method put into practice will either be confirmed or not, particularly as regards the number of sessions: changes and adjustments might be necessary, and in that case the new method will have to be defined, together with the new objectives and strategies, also considering the motivations of the patients under treatment.
With reference to the use of the Vibroacoustic Polisensory Bed, the therapist will motivate his choices on the basis of a sound-respondency test; he will also observe the subjects’ behaviour around the sessions (their movements, their comments and the like) and ask them to describe feelings and sensations as a result of the treatment at the end of each session. That description will be formulated through a list of closed-answer questions.
EVALUATIONS AND CONCLUSIONS
a. Improvement evaluation and statistical survey. The whole body of data will be checked at the end of the period in order to evaluate the real efficacy of the treatment. There will also be an informal interview with the participants to let them express their personal opinion and verify, together with the therapist, whether they have experienced a change. The interview will be followed by a biofeedback test.
All the results will also be examined within a statistical survey carried out through descriptive and inferential methods and addressed to single patients or homogeneous groups.
b. Analysis of the results. The results will be divided into 3 types:
- definite solution, meaning that anxiety, as a source of eating disorders, has been completely overcome and the patient has begun to lose weight;
- stable, where the anxiety status has become chronic, stopping at the level shown at beginning of the treatment; as a consequence, patients will signal neither weight losses nor weight gains.
- buffer solution, when the treatment did produce a real improvement, but it is likely to be only temporary: patients could have a relapse and then need further attention on behalf of the therapist.
c. Clinical evaluation. At the end of the cycle the whole treatment will be evaluated from a clinical viewpoint, with specific reference to the expectation/result ratio: in other words, the expectations of the beginning will be compared with the final outcome, signalling possible relapses or, on the contrary, the presence of durable results, the quality of which should be specified.
The clinical evaluation is thought as a support to the objective measurements carried out according to the methodology already mentioned.
The whole work should finally be checked isolating relevant values with a view of creating any possible statistical index of some interest.
d. Follow up. In order to have a more precise idea of the effectiveness of the treatment over time, the sampling unit will be monitored at home through a questionnaire that will be mailed after 2, 4 and 6 months; the simple questions to answer and send back to the Centre will be of the following type:
1. Have your eating disorders disappeared ? (yes, no, not completely)
2. Would you say that your life style has grown better?
3. Do you have any relapse to signal?
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Raffaelli Alberto - brain analyst
Barbina Adriana - scientific coordinator
Esposito Pier Luigi - physiologist
Fragiacomo Tullio - analyst
Kriscak Diego - viboracoustic therapist
Mullich Laura - psychotherapist
Rizzo Claudio - computer programmer
